None listed
Conditions
Brief summary
This study aims to investigate the effectiveness, safety, tolerability and blood levels, of twice daily ZYN002, in addition to regular seizure medication, for 12 weeks in 180 adults with partial onset seizures. This will be done by analysing a daily seizure and skin irritation diary, drug levels in the blood at various times following drug administration, and side effects. Skin at the application sites will be checked to see if there is any irritation or reactions present after applications. Who is if for? You may be eligible to join this study if you are aged between 18 and 70 years, have epilepsy with partial onset seizures and are currently on a stable regimen of AED(s). Study details: This study will investigate two doses of ZYN002 compared to a placebo gel (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means you and your study doctor, together with the study staff will not know whether you are receiving ZYN002 or placebo gel. What does study participation involve? Your participation in the study includes a screening visit; a baseline period of up to 8-weeks; a 12 week study treatment period; dose reduction at Week 13 and 14; and an end of study (EOS) visit at Week 15. Participants should fast prior to four study visits. Participants will be instructed to record their seizure frequency and type in their daily diary. During the baseline period, participants will record seizures in the daily diary, and blood samples will be collected at two visits. During the treatment period four clinic visits are required for: blood sampling; review of daily diary, medications, AEs and skin irritation; measurement of blood pressure, heart rate, breathing rate and temperature ; suicide risk; and possibly, a brief physical and neurological exam, pregnancy tests (females only, if applicable) and an ECG. Participants withhold their morning application until after blood sample collection at these visits. Two additional clinic visits are also required for blood sampling. Additional out-patient visits may be required if there is skin irritation present at the application site.
Interventions
Participants will undergo an 8-week baseline period to document their seizures and the medications they are taking to treat their epilepsy. Following the baseline period, participants will receive one of three treatments as indicated below:
- Treatment A: ZYN002 – CBD 195 mg every 12 hours, or
- Treatment B: ZYN002 – CBD 97.5 mg every 12 hours, or
- Treatment C: placebo every 12 hours
for 12 weeks.
Participants will have their dose reduced by 50% at Week 13 and another 50% (only participants
Participants will undergo an 8-week baseline period to document their seizures and the medications they are taking to treat their epilepsy. Following the baseline period, participants will receive one of three treatments as indicated below: - Treatment A: ZYN002 – CBD 195 mg every 12 hours, or - Treatment B: ZYN002 – CBD 97.5 mg every 12 hours, or - Treatment C: placebo every 12 hours for 12 weeks. Participants will have their dose reduced by 50% at Week 13 and another 50% (only participants receiving Treatment A) at Week 14, with no further treatment administered from week 15. ZYN002 or placebo gel will be applied to the skin of both the right and left shoulder and/or upper arms. Participants will bring used and unused sachets to each visit for site to check treatment compliance.
Sponsors
Zynerba Pharmaceuticals Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Eligible participants include males and non-pregnant, non-lactating females, with confirmed epilepsy, with Partial Onset Seizures (POS) for at least 5 years; who have on average at least three observable POS per month; who are being treated and maintained on a stable regimen of AED(s); who are able and willing to maintain a daily diary; and have an acceptable (protocol defined) body mass index (18-35 kg/m2). Females of childbearing potential and males with a partner of childbearing potential must use an acceptable method of contraception, from at least 21 days prior to the first dose of study drug and for 28 days after the last dose of study drug. Participants must agree to comply with all study restrictions and procedures, provide written informed consent and, in the investigator’s opinion, be reliable.
Exclusion criteria
Excluded are patients with a history of relevant allergic reactions; who have been exposed to any investigational drug or device in the last 30 days; who have used any marijuana-containing product within the last four weeks; who have changed tobacco product(s) use within the last 30 days; who have certain types of epilepsy or non-epileptic seizures within the last 5 years; who are using certain (protocol defined) AEDs or have changed AED regimen in the last 4 weeks; who have had epilepsy dietary therapy started within the last 3 months; who have any diseases or conditions that are likely to require changes in drug therapy during the study or interfere with the objectives of the study; who are at risk of suicide; who have Hepatitis or HIV; who have a positive drug screen for (protocol defined) drugs, including alcohol, or who have a history of alcohol or drug abuse.
Outcome results
None listed